A randomized, subject and investigator blinded, placebo controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa - Efficacy and safety of different investigational drugs for the treatment of hidradenitis suppurativa

ovartis Farmacéutica, S.A.0 个研究点目标入组 90 人开始时间: 2020年3月6日最近更新: 2020年11月30日

适应症

试验速览

暂无简介。

•- Male or female, age 18-65 years, at least 50 kg body weight with moderate to severe HS
•- Clinically diagnosed HS for at least 12 months prior to screening
•- For Cohort A (iscalimab): at least 5 inflammatory lesions, no more than 10 fistulae and at least two anatomical area involved with HS lesions
•- For Cohort B (LYS006): at least 3 inflammatory lesions; no more than 10 fistulae and at least two anatomical areas involved with HS lesions
•Other protocol-defined inclusion criteria may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 89
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•- Use of other investigational drugs at the time of screening, or within 30 days or 5 half lives
•of randomization, whichever is longer; or longer if required by local regulations; or
•longer if required by local regulations
•- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for the subsequent 14 weeks after the last study drug administration for Cohort A (iscalimab) and the subsequent 2 weeks after the last study drug administration for Cohort B (LYS006).
•- Pregnant or nursing (lactating) women at screening or randomization
•Other protocol-defined exclusion criteria may apply

发起方

ovartis Farmacéutica, S.A.